NCT04219865已完成1 期
Study on the Safety, Tolerance and Pharmacokinetics of Single-dose, Increasing and Loading Dose and Maintenance Dose Sequential Intravenous Infusion of Compound Edaravone Injection in Chinese Healthy Volunteers
Nanjing Yoko Biomedical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年6月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Area under curve (AUC) of edaravone and 2-aminoethanesulfonic Acid in single dose groups of compound edaravone injection
研究概览
简要总结
Study on the Safety, Tolerance and Pharmacokinetics of Single-dose, Increasing and Loading Dose and Maintenance Dose Sequential Intravenous Infusion of Compound Edaravone Injection in Chinese Healthy Volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-65 years old (including upper and lower limits);
- •Weight ≥50 kg, body mass index (BMI) between 18-28 kg / m2 (including upper and lower limits);
- •Understand and sign the informed consent voluntarily, and volunteer to participate in this research.
排除标准
- •A history of diseases of the heart, liver, lung, kidney, digestive tract, blood, or neuropsychiatric system judged by the investigator as clinically significant;
- •A comprehensive physical examination, neurological examination, laboratory examination, ECG examination, or cognitive assessment indicates that the subject has an abnormality that the researcher has determined to be clinically significant;
- •Have taken any drug within two weeks before the study administration, and the researcher believes that this situation may affect the evaluation results of this study;
- •There is a history of food or drug allergy or allergies that the researcher judges to be clinically significant;
- •Those with positive results of serological examination (HBsAg, anti-HCV, anti-HIV, TP-Ab);
- •A history of alcohol or drug abuse that the investigator believes may affect the evaluation results of this study within one year before the study administration;
- •Cannot quit smoking or drinking during the study period or the carbon monoxide breath test> 7 ppm during the screening period CO breath test, so if the subject's CO breath is> 7ppm, but the urine cotinine test is negative, it means that the CO breath test result may be false positive, the subject can be enrolled;
- •As a subject who has participated in any drug clinical trial within 3 months before the first administration of the study;
- •Those who donated blood or blood products ≥400 mL or 2 units within three months of the study;
- •Do not agree to avoid the use of tobacco, alcohol or caffeinated beverages, or vigorous exercise, or other factors that affect drug absorption, distribution, metabolism, excretion, etc. during the 24 hours before and during the test;
- •Pregnant or lactating women, or those who tested positive for serum HCG before the test administration, or those who were unable or unwilling to take researcher-approved contraception during the study according to the researcher's instructions;
- •Subjects with poor compliance or unable to comply with the relevant provisions of the research protocol due to personal reasons, the investigator judges that the subjects are not suitable to participate in this clinical study.
结局指标
主要结局
Area under curve (AUC) of edaravone and 2-aminoethanesulfonic Acid in single dose groups of compound edaravone injection
时间窗: 24 hours
Cmax of edaravone and 2-aminoethanesulfonic Acid in single dose groups of compound edaravone injection
时间窗: 24 hours
Cmax of edaravone and 2-aminoethanesulfonic Acid in multiple doses group after multiple intravenous infusion of compound edaravone injection
时间窗: 7 Days
Area under curve (AUC) of edaravone and 2-aminoethanesulfonic Acid in multiple doses group after multiple intravenous infusion of compound edaravone injection
时间窗: 7 Days
次要结局
- Incidence of adverse events of compound edaravone injection(7 Days)
研究者
研究点 (1)
Loading locations...
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